Enema device, and a delivery container for use in said enema device

ABSTRACT

The present invention relates to an enema device comprising a delivery container arranged for accommodating an enema and an applicator nozzle for dispersing the enema, and wherein the delivery container is arranged as a hand held pump and wherein a cross-section of said delivery container has the shape of an oval. Thereby is provided a simple, inexpensive and essentially maintenance free enema device which can be used for self-administrating of an enema.

CLAIM OF BENEFIT TO PRIOR APPLICATIONS

This application is a 371 filing of International Patent ApplicationPCT/DK2019/050291 filed Oct. 2, 2019, which claims priority to Danishpatent application PA2018/70651 filed Oct. 3, 2018.

TECHNICAL FIELD

The present invention relates to an enema device comprising a flexibledelivery container and an applicator nozzle.

BACKGROUND

Administrating an enema is a common medical procedure whereby fluid isinjected into the rectum and lower intestine of a patient in order toinduce bowel movement. The need for such a procedure typically arises inpatients suffering from certain physical ailments in which voluntarybowel control is impaired or when the bowel needs to be cleaned beforee.g. a coloscopy or a surgical operation.

Medical equipment currently exists in the art for administering an enemato patients in need of this procedure. At least one type of equipmentconsists of an enema squeeze bottle filled with the fluid intended toinduce bowel movement, which is capped by a short applicator nozzle tobe inserted into the patient's rectum. The applicator nozzle of thistype of conventional enema application device often causes discomfortand irritation when being inserted.

Furthermore, the force required to squeeze the liquid from an enemadispenser affects the ease with which a user may administer the liquid.The self-administration of a conventional enema may be especiallydifficult for patients have poor dexterity, e.g. due to the squeezeforce required to deliver a complete dose of the enema liquid.

Although it would be advantageous to decrease the amount of squeezeforce required to administer an enema, such a modification may adverselyaffect other desirable features of the device. In particular, it isdesirable to prevent any reflux of liquid back into the deliverycontainer after the enema liquid has been delivered, and it is desirableto prevent leakage of the enema liquid from the dispenser prior to use.A simple reduction in the resistance to flow of the liquid through thedevice may compromise these features.

Moreover, enemas are often administered to a patient at home when theneed for medical assistance does not necessitate a doctor or anotherhealth care assistant.

However, it is often difficult for the patient to administer the enemato him or herself since the applicator nozzle not only must be insertedinto a sensitive area, but the administration position is alsoinconvenient for the user making it is difficult for the patient toadminister the liquid while steadily holding the enema in the requiredarea. Often the patient is assisted by another individual; however,assistance may not always be available, if, for instance, the patientlives alone. Thus, there is also a need for an enema device that can beeffectively self-administered.

Such an enema device is e.g. known from WO2010122537, disclosing adevice which can be used for administrating an enema. Said enema deviceensures that uncontrolled flow of liquid into or out of the device isprevented by using two one-way valves, one for delivering the liquid andone for refilling the device.

The enema is administered by squeezing the delivery container, and afterreleasing the compression force, the container may either be re-inflatedby drawing surrounding air into the container via a first one-way valve,or the container may be re-loaded with enema by drawing enema into thecontainer via said one-way valve.

The latter will ensure that the device can be used for severaladministrations as needed by the user, however studies and userfeed-back have shown that most user can not get a convenient grip on thedelivery container, nor does they not have the strength to provide aconstant pressure on the delivery container. According the user willfirst administer a small amount of enema, then release the pressure onsaid container and after a short period administering a further smallamount of enema. However, when pressure is released on the deliverycontainer, air will unintentionally be drawn into the container andmixed with the enema. Air will then be delivered to the colon when thenext dosage of enema is administered. This will cause uncomfortabledistending of the colon causing pain and cramps. Thus, in order to avoidintake of air, the user will have to apply a constant pressure to thedelivery container during the administrating procedure, which may bedifficult for users/patients having weak fingers, e.g. due to arthritisor the like.

Furthermore, as air drawn into the container, expelling of the enemabecomes increasingly more difficult. Due to density differences betweenair and the enema, the device has to be oriented correctly, in order toprevent or reduce administration of air. However, ensuring such anorientation is almost impossible as the enema often is administered onthe toilet or in the bed, where the user's/patient's position preventssuch an orientation.

Since administration of air will cause discomfort several reloadings ofthe container with enema are often required in order to deliver aneffective dosage of enema and at the same time prevent delivery of air.However, reloading of the container requires easy access to the enema.If the enema for instance is tap water, a user sitting on the toilet,may use the sink as an enema reservoir, however, often the toilet andthe sink are to far apart for this to be manageable. Thus, the user hasto have a reservoir of enema nearby in order to provide easy reloading,making the reloading both difficult and troublesome.

Thus, there is a demand for a new enema device, which is simple and easyto use and which solves the limitations and disadvantages of the priorart.

SUMMARY OF THE INVENTION

It is therefore a first aspect of the present invention to provide ahandheld enema device that safely and effectively can administer anenema to a patient without causing discomfort.

It is a second aspect of the present invention to provide an enemadevice where the liquid is easier to administer, and where aireffectively is prevented from being mixed with the enema.

It is a third aspect of the present invention to provide an enema devicein which an effective dosage of enema can be administered withoutrequired reloading of the delivery container.

It is a fourth aspect of the present invention to provide an enemadevice that prevents reflux of liquid into the container after useand/or prevents leakage of the fluid prior to use.

In a fifth aspect according to the present invention is provided anenema device that is inexpensive to manufacture and is simple andreliable to use.

In a sixth aspect according to the present invention is provided anenema device that is relatively small and easy to operate, especially byone hand.

In a seventh aspect according to the present invention is provided anenema device arranged to delivery an enema to a patient sitting on thetoilet, without requiring reloading with enema.

The novel and unique whereby these and further aspects are achieved isthe fact that the enema device according to the present inventioncomprises a flexible delivery container arranged for accommodating anenema, and an applicator nozzle for dispersing the enema, and whereinthe delivery container is arranged as a hand held pump and wherein across-section of said delivery container has the shape of an oval, andwherein the delivery container comprises one or more compression zones,arranged for providing a controlled compression of said deliverycontainer.

Since the delivery container has a substantially oval cross-section,taken in a horizontal plane when the container is placed in a positionof use, it is easier for the user to apply pressure to the sides of thedelivery container. In contrast to a delivery container having acircular cross-section, a user will intuitively place/rest the deliverycontainer according to the invention in a specific orientation in theusers palm, allowing the user to compress the container by applyingpressure to the two longer curved sides of the delivery container usingboth the finger and the palm, e.g. the thenar muscles at the base of thethumb. This will not only ensure a pleasant and comforting fit in thehand but will also reduce the necessary force needed to compress thecontainer as well as reducing any awkward postures.

Thereby is provided a simple, inexpensive and essentially maintenancefree enema device which can be used for administrating enema, andwherein it is the delivery container itself which functions as a pump,i.e. the enema is expelled with the user applies pressure to the sidesof the pump, i.e. the delivery container is arranged as a hand heldpump. Accordingly the enema device according to the invention can beoperated without any external pumping means, making said enema deviceaccording small and compact, i.e. the enema device take up as littlespatial space or volume as possible, not only ensuring that the devicecan be handheld and easily operated e.g. with a single hand, but alsothat the enema device easily can be fitted into a bag or the like.

In a preferred embodiment the delivery container comprises a bottomsection with a first cross-section in the shape of an oval, and a tosection with a second cross-section in the shape of an oval, and whereinthe minor and/or the major axis of the first cross-section is largerthan the minor and/or the major axis of the second cross-section. Inorder to provide a user friendly delivery container, it is preferredthat the bottom section tapers towards the top section, i.e. that asmooth transition between the two sections is provided. It isaccordingly preferred that the delivery container is shaped as anelongated bulb, both assisting in ensuring that the user can applypressure to the sides of the container and that a comfortable feel inthe hand is provided. Accordingly, the enema device according to thepresent invention provides an easy expelling of enema withoutcompromising the structural features of the device. The device may in apreferred embodiment have a substantially flat base, such that thedelivery container may stand upright e.g. during and/or after fillingsaid container with enema, as this effectively will prevent spilling ofthe enema.

It is preferred that the delivery container will have a cross-section inthe shape of an oval irrespectively of where said cross-section is madein the delivery container, i.e. the oval shape continues in the completeheight of the delivery container. The oval may be any kind of oval, itis however preferred that the oval can be clearly distinguished from acircle, as the inventors of the present invention has found that usersexperience difficulties with applying pressure to a delivery containerhaving a cross-section in the form of a circle, e.g. that the userscannot expel an effective dosage of enema with such containers.Accordingly, the ratio of the minor axis to the major axis of said oval⅔ or lower, i.e. if the major axis is 3 cm, then the minor axis is 2 cmor lower, if the major axis is 4.5 cm, then the minor axis is not morethan 3 cm, etc.

Even though it is preferred that the oval of the first and secondcross-section are identical in shape (even though they have differentsizes), said ovals may also have different shapes. It is howeverpreferred that the size and dimensions of the ovals of the respectivecross-sections are selected such that the resultant elongatedbulb-shaped delivery container is arranged for resting firmly in thehand of the user, and that the user intuitively will hold the deliverycontainer in a cupped hand, allowing the user to apply pressure to thetwo longer sides of said container using the palm and fingers. A personskilled in the art will understand that the use may apply pressure tothe delivery container in any desired way, however, the oval-shaped bulbcontainer may ensure that the user will place the container in a cuppedhand.

In a preferred embodiment, the enema device comprises a non-returnvalve, such that when the patient/user released the compression force onthe delivery container, the first non-return valve will effectivelyprevent backflow of fluid, e.g. air, liquid and faeces from the colonand/or rectum into the enema device. Accordingly, any contamination ofthe delivery container and it's remaining content, which may occurduring and/or after administration of the enema to a patient isprecluded.

The non-return valve may e.g. be placed in the applicator nozzle, e.g.at or near an outlet on said nozzle. This may e.g. be preferred if theapplicator nozzle is reused, otherwise it will be a less expensivesolution to place the non-return valve in the enema device according tothe invention.

Such non-return valves are well known in the art, and may be any valvecapable of providing the desired properties, e.g. prevent intake ofair/fluid etc. to the enema device according to the invention e.g. swingvalves, ball valves, diaphragm valves, butterfly valves, and the like.

The non-return valve further has the advantage, that if the user duringthe administration procedure releases the compression force on thecontainer, air will be prevented from being drawn into the deliverycontainer. Accordingly, air cannot be administered into the patientscolon and unnecessary discomfort caused by distending of the colon byair, is effectively prevented.

Furthermore, when the enema is expelled during the administrationprocedure, the delivery container will collapse, and since thenon-return valve will prevent any intake of e.g. air into the container,the delivery container will remain in a collapsed state, even if theuser releases the pressure on said container. This ensures that usereasily can expel the remaining content from the delivery container, byalternating applying pressure and releasing said pressure from thecontainer, until the desired dosage or the entire enema content has beenexpelled from the enema device. As the delivery container collapses whenthe enema is expelled, the user can furthermore easily fell when theenema has been expelled thereby providing a simple indication to theuser, when the desired e.g. entire dosage of enema has beenadministered, i.e. when the delivery container is in a complete orsubstantially complete compressed condition.

In order to obtain said advantage, it is preferred that the enema deviceaccording to the invention does not comprise any means for drawing airand/or fluid into the delivery container during the administrationprocedure.

The delivery container is arranged as a hand held pump and mayaccordingly be made of a resilient deformable material with a memory,e.g. silicone, a thermoplastic polymer, polyurethane,polyvinyl-chloride, or a similar soft polymer. This means that the usercan apply pressure on the delivery container, whereby the container willcollapse and enema is forced out though the applicator nozzle attachedto the enema device.

In order to provide a controlled compression of the delivery container,said container comprises one or more compression zones. The compressionzones may further be arranged for ensuring that when a compression forceis applied to the delivery container, said container willcollapse/compress in such a way that substantially the entire content ofthe enema device is expelled.

Within the context of the present invention, the term “compression zone”means an area/section of the delivery container having a differentdesign/construction/configuration than the remainder of said container.

The compressions zones may be provided in a number of different manners.It is in this respect preferred that the compression zones constitutes aminor portion of the delivery container, and preferably less than 50% ofthe surface area of the delivery container, preferably less than 30% ofsaid surface area, thereby providing a controlled compression of saidcontainer.

In one embodiment the compression zones may be provided by adjusting thewall thickness of the delivery container in one or more compressionareas, such that in areas where a large compression force is desired,e.g. at the bottom of the delivery container, the wall thickness of saidcontainer is larger than in areas e.g. at the sides of said container,where is lower compression force is desired. In a preferred embodiment,the bottom section of the delivery container will have a largercompression force, and accordingly a larger wall thickness, than the twosmall sides of the delivery container. Furthermore, the two longer sidesof said container will have an even smaller compression force, than thetwo small sides, and accordingly a small wall thickness. In this way itis ensured that when the user applies pressure to the deliverycontainer, said container will tend to collapse more at the longersides, etc, thereby providing a controlled collapse. The compressionareas may be one or more surface of the delivery container, but may inan preferred embodiment be one or more limited areas of said container,e.g. two opposing circular areas on the two longer sides of the deliverycontainer and/or two opposing circular areas on the two smaller sides ofthe delivery container, and/or a single circular area at the bottom ofthe delivery container. In a different embodiment one or more of saidcompression areas may further be arranged for notcompressing/collapsing/bending, even when a large compression force isapplied to said area, whereby it is possible to adjust/control thecompression of the delivery container even further.

Instead of altering the wall thickness of the delivery container atcertain compression areas, the compression zones may also be provided byreducing the wall thickness of the delivery container in one or morebending lines arranged at relevant locations in the delivery container.In one embodiment the bending lines may have the same depths, i.e. thewall thickness are the same for all bending lines, and/or have the samecutting angle, e.g. resembling a V, however a person skilled in the artwill understand that the wall thickness and/or cutting angles of saidbending lines may vary in order to adjust the required bending force ofthe compression zones. Furthermore, the extension and/or shape of thebending lines may vary, and may in one embodiment extend from the bottomof the delivery container to the top, i.e. in the complete height of thedelivery container, and in another embodiment extend only in a part ofthe delivery container, be circular, triangular etc.

Alternatively, the compression zones may be provided by providingreinforcement ribs at the inside and/or outside of the deliverycontainer. Said reinforcement ribs may have any desired shape andlocation and may accordingly be lines, be circular, be a section of acircle nave polygonal shape, etc.

The one or more compression zones of the delivery container may also beobtained by providing a delivery container made of differed kinds ofmaterial, and wherein the respective materials have a differentharnesses, such that said the delivery container can be easier deformedin certain areas than in others.

Thus, the compression zones may be providing in different ways, e.g.using one or more of the possibilities discussed above, be placedsymmetrically or asymmetrically on the delivery container, etc. howevera person skilled in the art will understand that said compression zonesmay also be obtained in other ways, the only requirement being that acontrolled compression of the delivery container is provided.

In order to ensure that the enema device according to the invention canbe used by patients/users having week fingers, the delivery containermay in an advantageously embodiment be arranged such that is may befully compressed by a force of less than about 150 N, preferably lessthan 130 N, and even more preferred by a force less than 110 N. However,in order to prevent the delivery container from collapsing to early,i.e. during the handling of the enema device before the administrationprocedure is initiated, it is preferred that that a compression force ofat least 30 N has to be applied before the delivery container startcollapsing/compressing. However, it is further preferred that thedelivery container is arranged for compressing when a compression forceof not more than 50 N is applied to the delivery container, e.g. the twolonger sides by the palm and fingers. The desired forces used tocompress the delivery container may e.g. be obtained by using specialmaterials, adjusting the wall thickness of the delivery container, usingthe compression zones, etc.

In a preferred embodiment the delivery container is arranged forexpelling at least 80-vol % of the enema accommodated in the deliverycontainer, preferably at least 90 vol % and even more preferredsubstantially the entire content, when the delivery container is fullycompressed or at least when the user cannot compress the deliverycontainer further during the administration procedure.

In a preferred embodiment the delivery container is arranged foraccommodating at least an effective dosage of enema, preferably slightlymore. Within the context of the present invention the term “an effectivedosage of enema” means the amount of enema which is required and/orsufficient for stimulating stool evacuation in the patient. Even thoughan effective dosage is individual, among others depending on the age ofpatient (e.g. child vs. adult) administration of enemas is well known inthe art, and a person skilled in the art will have no problem ofestablishing an effective dosage of enema.

In one embodiment, the delivery container is arranged for accommodatingat least about 90 ml of enema, and preferably at least about 130 mlwhich is slightly more than a conventional enema dosage for most adults.As the required amount of enema is individual, the enema device may insome preferred embodiments accommodate about 150 ml or even up to 250ml, however the dimensions of said enema device may be adjusted toaccommodate a higher or lower amount of enema, within the content of thepresent invention.

Using an enema device arranged for accommodating an effective dosage ofenema, ensures that the user can administer a full and effective dosageof enema, without having to reload the device, and without having toworry about air being mixed with the enema. Accordingly, thepatient/user can release the pressure on the delivery container as manytimes as desired, and the administration of the enema can take as longas the patient need or require without compromising the function of theenema device according to the invention, whereby a high patientcompliance is provided.

Thereby is provided an enema device which is highly suitable forself-administration, as the effort required to expel the enema liquid issignificantly reduced compared to the known enema devices.

In order to ensure that the enema is administered with a relatively highpatient compliance, the enema device according to the invention isarranged for being connected to an applicator nozzle that preferably isarranged for alleviating the physical discomfort and pain that thepatient may expire during insertion of the applicator nozzle. Saidapplicator nozzle is in fluid communicating with the delivery container,such that said enema can be expelled via an outlet in the applicatornozzle. As the applicator nozzle is inserted into the rectum of thepatient, it is preferred that said applicator nozzle is releasablyconnected to the enema device, in order to allow said applicator nozzleto be either cleaned or discharged.

In order to facilitate refilling and re-use of the enema deviceaccording to the invention, it is preferred that the enema device can berestored to an initial position, i.e. a position where the enema deviceis ready for a new enema administration procedure. It is in this respectpreferred, that the delivery container is arranged for being opened andclosed, in order to allow an easy refilling of said container withenema. It is in this respect preferred that the enema device comprises aclosure member comprising a first closure part arranged for beingattached to the delivery container, and a second closure part arrangedfor being separating from or connected to, the first closure parts,respectively opening and/or closing the delivery container.

Such closure member are known in the art and includes threaded closuremember, snap-fit closure member, closable lids, etc. It is howeverpreferred that the closure member is a hinged closable lids, as thisprovides a simple embodiment in which it is ensured that the parts ofthe closure member cannot be misplaced. A fluid tight seal is preferablyprovided between the first and second closure parts when the closuremember is in a closed position, in order to prevent leakage of theenema.

In a simple embodiment the non-return valve is incorporated into theclosure member, whereby said valve can be reused, even if the applicatornozzle is discharged.

It is further preferred that when the second closure part isremoved/separated from the first closure part, a first opening isprovided into the delivery container, and that said first opening has asize that allows an easy manual refilling of enema into the deliverycontainer. It is accordingly preferred that said first openingconstitutes at least 50% of a cross-section taken at the top section ofthe delivery container, preferably at least 60%, and even more preferredat least 80% of the cross-section taken at the top section of thedelivery container. A relatively large opening into the deliverycontainer will also allow the inside of the delivery container to beeffectively cleaned and dried between different enema administrations,thereby providing a more hygienic enema device than hitherto known.

The second closure part may in a preferred embodiment comprise acoupling unit arranged for releasably connecting the applicator nozzleto the enema device and for providing a fluid communication between theapplicator nozzle and the delivery container. Accordingly, the secondclosure part may comprise a second opening in fluid communication withthe delivery container via the first opening, such that enema in thedelivery container can be expelled via said applicator nozzle.

The closure member may in one embodiment be made of a rigid material,e.g. polypropylene or polyvinyl chloride, thereby not only ensuring thatthe closure member can be opened/closed but also that the applicatornozzle easily can be releasable attached to the closure member. Saidapplicator nozzle may be attached to the closure member in anyconventional and convenient way, e.g. using a snap-fit, or the like,however in a preferred embodiment the applicator nozzle comprises a tubedefining an inlet at one end, and wherein said tube can be sealinglyinserted into the second opening.

In order to ensure a fluid tight seal between the closure member and thedeliver container, said closure member may preferably be attached to thedelivery container via an intermediate member, preferably matching theoval shape of the top section of the delivery container. Saidintermediate member is preferably also made of a rigid material, and maybe integrated with the second closuring part, and may be attached to thetop section of the delivery container via an adhesive or the like.

The term “enema” covers any liquid, which is capable of promoting bowelmovement when introduced into the rectum and colon, such as an enemaliquid. Examples of enema liquids include water; hypertonic aqueous saltsolutions; solutions or suspensions of cathartic agents, such asbisacodyl or phenolphthalein; and mineral oil. Other liquids capable ofpromoting bowel movements are well known in the art, and are alsocontemplated within the scope of the present invention. It is howeverpreferred that the enema has a low viscosity that ensures that the enemaeasily can be distributed evenly in the colon, e.g. a viscositycorresponding to or being close to the viscosity of water. Gels orliquids having a high viscosity i.e. they cannot flow easily, isaccordingly not preferred.

The applicator nozzle may have any shape so long as the nozzle is ableto perform the function of administrating the enema to the patient'srectum and/or colon. In a preferred embodiment the applicator nozzle hasa mainly frustoconical shape whose outside diameter progressivelydecreases from it's proximal end to it's distal as said shapeautomatically will ensure a tight fit with the anal opening.

The applicator nozzle can furthermore be modified in size, shape andpossibly other physical properties such as flexibility, rigidity andpliancy to become a plug that accommodates forming a sealing fit withthe anal opening. For example, if at least the nozzle is somewhatpliable, it will conform to the shape of the patient's rectum and aid inalleviating the physical discomfort and pain that the patient may expireduring insertion of the nozzle.

The nozzle can furthermore be provided with e.g. a pointed blunt tip inorder to further reduce said discomfort, a lubricant or an activatedhydrophilic coating in order to aid the insertion of the nozzle in therectum by reducing frictional force.

The applicator nozzle can preferably be disposable in order to reducecontamination of the surroundings e.g. by providing a nozzle, which canbe flushed down the toilet after use. This will also make the devicemore convenient and hygienic in use, however said nozzle may also, ifdesired, be arranged for being reused after being cleaned and/orsterilised. In any case it is preferred that the applicator nozzle ismade of a hypoallergenic material that is non-reactive with thepatient's tissue.

The enema device according to the present invention has a simple anduser-friendly design, making it extremely easy to operate with a singlehand ensuring that the device can be unassistedly used in privacy. Whena new administration proceedings is to be initiated, the user can easilyrefill the delivery container with enema, close the closure member andconnect an applicator nozzle to the delivery container, whereby theenema device according to the invention is ready for the next enemaadministration.

The user can then placed the enema device in a cupped hand, and applypressure to the sides of the delivery container. As air, faeces orliquid cannot be drawn into the delivery container, the user can reducethe pressure, e.g. simply holding the enema device in place, and reapplypressure at the users convenience until the delivery container issufficiently compressed e.g. completely, and the desired dosage of enemahas been delivered to the colon.

After the administration procedure is completed the user can e.g.discharge the applicator nozzle, open the closure member whereby airwill enter the delivery container and return said container to it'soriginal shape. The relatively large first opening into the deliverycontainer will further ensure that the delivery container can be cleanedand dried between the administration procedures.

In a preferred embodiment the delivery container has a height of about 7cm, and the cross-section of the bottom-section has minor axis of 2.50cm and a major axis of 3.75 cm, the cross-section of the top section hasa minor axis of 2.00 cm and a major axis of 3.00 cm, and the firstopening is a circle having a radius of 1.75 cm.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be explained in greater detail below, describing onlyexemplary embodiments of the enema device with reference to the drawing,in which

FIG. 1 shows a perspective view of an enema device according to thepresent invention with a first embodiment of a delivery container,

FIGS. 2a-2b show exploded perspective views of the enema device shown inFIG. 1 seen from the bottom and top, respectively,

FIGS. 3a-3b respectively illustrates the cross-section of the deliverycontainer taken along the lines IIIa-IIIa and IIIb-IIIb in FIG. 1,

FIGS. 4a-4b . show exploded perspective views of the closure member seenfrom the top and bottom, respectively,

FIG. 5 shows a cross-sectional view of a second embodiment of the enemadevice,

FIG. 6 shows a second embodiment of a delivery container according tothe invention,

FIG. 7 shows a cross section of a third embodiment of a deliverycontainer according to the invention,

FIG. 8a shows a cross section of the delivery container taken along thelines VIII-VIII in FIG. 7, and

FIG. 8b shows the enlarged section C of FIG. 8 a.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1. is a schematic view of a first embodiment of the enema device 1according to the invention, and FIG. 2 is the same in an exploded view.Said device consist basically of an enema delivery container 2, arrangedas a hand held pump having a cross-section that is substantially oval,an applicator nozzle 3 and a closure member 4. The applicator nozzle 3has an exit opening 5 through which the enema can be expelled whenpressure is applied to the delivery container 2.

In the embodiment shown in FIG. 1 and FIG. 2 the delivery container 2comprises an opening 6, a bottom section 7 with a first cross-section 8in the shape of a first oval 9, and a) section 10 with a secondcross-section 11 in the shape of a second oval 12. FIG. 3a shows thefirst oval taken along the lines IIIa-IIIa in FIG. 1, and FIG. 3b showsthe second oval 12 taken along the lines IIIb-IIIb of FIG. 1.

The major axis Xa and the minor axis Ya of said first oval 9 is largerthan the major axis Xb and the minor axis Yb of the second oval 12, andthe bottom section 7 tapers towards the two section 10 such that asmooth transition 13 between the two sections 7,10 provide whereby thedelivery container 2 obtains the shape of an elongated bulb 14 as shownin e.g. FIG. 1, having a base 15 allowing the enema device 1 to rest ona surface (not shown), two longer curved sides 16 a,16 b, and twoshorter curved sides 17 a,17 b.

The base 15 further ensures that enema device 1 may stand in an uprightposition both when said container is filled with enema, and duringhandling of said device 1, e.g. when closing the closure member 4 andconnection of the applicator nozzle 3.

The delivery container 2 has a cross-section in the shape of an oval9,12 irrespectively of where said cross-section is made in the deliverycontainer 2, i.e. the oval shape continues in the complete height H ofthe delivery container 2. The oval cross-section(s) 8,11 and theelongated bulb-shape 14 of the delivery container 2 ensures that it iseasier for the user to apply pressure to e.g. the sides 16 a,16 b of thedelivery container 2. The user will intuitively place/rest the deliverycontainer 2 with the bottom in the users palm, whereby it will be easyto compress the container 2 by applying pressure to the two longercurved sides 16 a,16 b of the delivery container 2 using both the fingerand the palm, e.g. the thenar muscles at the base of the thumb. Thus,the use of an oval cross-section 8,11 will provide a pleasant fit in thehand of the user as well as reducing the compression force required tocompress the container 2. A person skilled in the art will understandthat the user may apply pressure on the delivery container 2 in adifferent manner if desired, e.g. having the palm of the hand restingagainst one of the two shorter curved sides 17 a,17 b of the deliverycontainer 2.

FIGS. 4a and 4b show exploded perspective views of the closure member 4seen from the top and bottom respectively. Said closure member 4comprises a first closure part 18 arranged for being attached to the top19 of the delivery container 2 via an intermediate part 20, and a secondclosure part 21 arranged for being separating from or connected to thefirst closure part 18 via a hinge member 22 and a click-fit connection23. In this way the closure member 4 functions as a hinged closable lid,having the advantages that the second closure part 21 cannot bemisplaced during use. Furthermore, the click-fit connection 23 ensuresthat the user knows when the closure member 4 is closed i.e. when afluid tight seal is provided between the first and second closure parts18,21, in order to prevent leakage of the enema. A person skilled in theart will understand that the shown closure member 4 is one of manypossibilities of providing an opening 6 into the delivery container 2,and that others, e.g. threaded closure members, also are contemplatedwithin the scope of the present invention. Sealing rings (not shown) orthe like, may be used, if necessary, in order to ensure that the liquidtight seal is obtained.

The intermediate part 20 is permanently and securely connected to theinside of the top 19 of the delivery container 2, e.g. using a glue,welding or similar means, thereby providing a reliable and durableconstruction, in which the closing member in a simple manner can be openand closed. However, the intermediate part may also be connected withthe delivery container using an overmoulding process, a 2 K injectionmoulding process, and/or a similar process, the only requirement beingthat the closure member 4 is securely connected to the deliverycontainer 2.

In order to ensure that the enema can be expelled from the deliverycontainer 2, the first closure part 18 comprises a first opening 24 andthe second closure part 21 comprises a second opening 25, which togetherprovides a fluid communication between the delivery container 2 and theexit opening 5 of the applicator nozzle 3 when said nozzle is attachedto the closure member 4.

In the embodiment shown in the figures, the applicator nozzle 3 isremovable connected to the closure member 4 by means of a coupling unit26. This is best seen in FIG. 2. Said coupling unit ensures that theapplicator nozzle 3 can be removed after use and then be either cleaned,sterilised or simply discarded.

The coupling unit 26 consist of a female coupling part 27, placed in thesecond coupling part 21 and extends into the second opening 25, and isarranged for engaging a male coupling part 28 placed on the applicatornozzle 3. In the embodiment shown the male coupling part 28 is a shortflexible tube 29, extending via an inner tube 30 in the applicatornozzle 3, to the exit opening 5. The female coupling part 27 is made ofa rigid material, such that a liquid tight seal is provided between thetwo parts 27, 28 and when they are engaging. The male coupling part 28has a tapered end 31 for facilitating a simple engagement with thefemale part 27 when the male coupling part 28 is inserted into andretracted from the female coupling part 27.

The applicator nozzle 3 further comprises an annular, substantiallyfrustoconical extension 32, which not only provides a comfortable designfor the user and a tight fit with the anal opening during theadministration proceedings, but also a stop for limiting the extensionof the male coupling part 28 into the female coupling part 27 when thetwo parts are connected. Thereby is an especially simple and inexpensivedesign of the enema device 1 according to the invention obtained.

In the embodiment shown, the applicator nozzle 3 has a single exitopening 5 at its distal end 33. In a variant, several exit openings maybe formed at the distal end 33 of the applicator nozzle, 3 including oneor more orifices (not shown) located at offset locations along thesurface of the distal end of the applicator nozzle. This offsetconfiguration for the location of the exit openings may be particularlydesirable where the user's rectum or colon is inflamed or otherwisesensitive to contact by a pressurized stream of fluid.

As is best seen in FIG. 4b a cylindrical valve seat 34 for a non-returnvalve (not shown) is sealingly fitted into the second closure part 21via a corresponding cylindrical rim 35 arranged on the inside 36 of saidsecond part 21, such that backflow of fluid e.g. air, liquid and faecesfrom the colon and/or rectum into the enema device effectively isprevented at the second opening if/when the patient/user released thecompression force on the delivery container. The valve seat 34 comprisesthree openings 37 which may be closed with e.g. an umbrella valve as thenon-return valve.

The closure member 4 is preferably made of a rigid material, e.g.polypropylene or polyvinyl chloride, thereby not only ensuring that theclosure member 4 can be opened/closed but also that the applicatornozzle 3 easily can be releasable attached to the second closure part.As is best seen in FIG. 4b , the first opening 24 is relatively large,i.e. it both allow an easy manual refilling of enema into the deliverycontainer 2, and that the inside of the delivery container 2 can becleaned and dried between different enema administrations. In theembodiment shown, the first opening 24 constitutes an area of about 60%of the area A of the cross-section 11 taken at the top section 10 of thedelivery container 2, however a person skilled in the art willunderstand that said size may vary if desired.

FIG. 5 shows a cross-sectional view of a second embodiment of the enemadevice 1′. Said embodiment corresponds to the embodiment shown in FIGS.1-3 with the difference that the closure member 4′ is modified. Thus,for like parts the same reference number is used. In the secondembodiment 1′, the closure member 4′ does not comprise a valve seat 34,instead the second opening 25 of the second closure part 21 comprises abase 38 having openings 37, to which a non-return umbrella valve 39 isfitted.

FIG. 6 shows a second embodiment of a delivery container 2′ for use inan enema device 1 according to the invention. Said embodiment 2′corresponds to the first embodiment of the delivery container 2, withthe modification that a number of compression zones 40 are provided inthe delivery container 2′. Accordingly, the same reference numbers areused for like parts. The compression zones 40 are in the embodimentshown defined by two opposing circular areas 41 a,41 b on the two longercurved sides 16 a,16 b of the delivery container 2′, two opposingcircular areas 42 a,42 b on the two smaller sides 17 a,17 b of thedelivery container 2′, and a single circular area 43 at the base 15 ofthe delivery container 2′. The top section 10 of the delivery containerwill be reinforced by the intermediate section 20 from the closuremember 4, and will accordingly not be able to be compressed to asignificant degree. However, the different circular compression areas 40may have different harnesses e.g. thicknesses and accordingly bearranged to bend/yield when different forces are applied to said areas40. For instance the force needed to compress the delivery container atthe circular area 43 at the base 15, may be lager than the forces neededto compress the delivery container at the two opposing circular areas 42a,42 b on the two smaller sides 17 a,17 b of the delivery container 2′,and the force needed to compress the delivery container at the twoopposing circular areas 41 a,41 b on the two longer curved sides 16 a,16b may be the lowest. In this way it is ensured that when a user providespressure to the delivery container 2′, said container willcollapse/compress in such a way that substantially the entire content ofthe enema device is expelled.

The compressions areas may be provided by adjusting the wall thicknessof the delivery container in the compression areas 40, e.g. such thatthe wall thickness in compression areas 41 a,41 b on the longer sides isthe lowest, and the compression area 43 at the base is the highest.Alternatively, the different compressions areas 40 may be made ofdifferent materials having different hardness, have differentcurvatures, e.g. double curvatures and the like.

A person skilled in the art will understand that more or fewercompression areas 40 may be provided, each having differenthardness/wall thickness. Said compression areas need not be circular,but may have other desired shapes, e.g. be triangular, etc. Furthermore,one or more of said compression areas may be arranged for not collapsingat all, even if a large compression force is applied to said area.

FIG. 7 shows a third embodiment of the delivery container 2″ accordingto the invention, in which the compression zones 40 are provided byreducing the wall thickness X of the delivery container in two bendinglines 44 arranged at one of the long curved surfaces 16 a, a crosssection 45 taken along the lines VIII-VIII is shown in FIG. 8a . Thebending lines are shaped as a V, see enlarged view of a bending line inFIG. 8b , have the same cutting angle α, and the same depths d, i.e. thecharacteristics of the bending lines are the same for the two bendinglines 44. However a person skilled in the art will understand that saidbending lines and/or the shape of the bending line and/or the depth(wall thickness) and/or cutting angles of said bending lines may vary inorder to adjust the required bending force of the compression zones.Furthermore, the number of bending lines and/or placement of saidbending lines may be adjusted.

Alternatively, the compression zones may be provided by providingreinforcement ribs (not shown) at the inside and/or outside of thedelivery container. Said reinforcement ribs may have any desired shapeand location and may accordingly be lines, be circular, be a section ofa circle, have polygonal shape, etc.

When an enema is to be administered an enema, e.g. saline or tap water,is filled into the delivery container 2,2′,2″ via the first opening 24,then closing the closure member 4 and place an applicator nozzle 3 onsaid closure member 4 via the coupling unit 26. In order to prevent airfrom being entered into the colon, it is preferred that the deliverycontainer 2,2′,2″ is completely or at least substantially filled withsaid enema.

In order to initiate the administration procedure, the applicator nozzle3 is then placed in the patient's anal opening and it is ensured thatthe nozzle 3 provides a tight fit with the opening.

Compression force is then applied to the delivery container 2,2′,2″ bysqueezing the delivery container. The enema is allowed to flow throughthe first 24 and second 25 opening, into the tube 30 of the applicatornozzle 3 and out of the exit opening 5, resulting in the enema beinginjected into the rectum and colon.

When the user during the administration procedure releases thecompression force on the delivery container 2,2′,2″, said container willremain compresses as the non-return valve 39 will prevent fluid fromentering the delivery container. Furthermore, since the non-return valve39 effectively prevents air from being mixed with the enema, air cannotbe administered into the patients colon and unnecessary discomfortcaused by distending of the colon by air, is effectively prevented.

After each squeezing and subsequent release action the deliverycontainer 2,2′,2″ will be more and more compressed, gradually reducingthe size of said container, allowing the user to fell when the desireddosage of enema has been administered, or the entire enema content hasbeen expelled from the device.

After the enema is administrated into the rectum and/or colon the enemadevice 1 is removed from the anal opening, and the applicator nozzle 3can be detached from the delivery container 2,2′,2″ and either bediscarded or cleaned for later use. The second closure member 21 canthen be released from the first closure member 18, allowing the insideof the delivery container 2,2′,2″ to be cleaned and/or dried via thefirst opening 24. When a new administration procedure is to beinitiated, the enema device 1 can be restored to it's initial positionby refilling the delivery container 2,2′,2″ with enema as alreadydescribed.

Since the enema device 1 according to the invention are relatively smalland intended for use with a single hand, it can used equally well forboth home-administrations of enema or for the use in medical or hospitalfacilities where larger irrigations/enema devices are too troublesomeand complicated to use.

Modifications and combinations of the above principles and designs areforeseen within the scope of the present invention.

The invention claimed is:
 1. An enema device (1) comprising a flexibledelivery container (2,2′,2″) arranged for accommodating an enema and anapplicator nozzle (3) for dispersing the enema, and wherein the deliverycontainer (2,2′,2″) is arranged as a hand held pump and wherein across-section of said delivery container (2,2′,2″) has the shape of anoval, and wherein the delivery container (2,2′,2″) comprises one or morecompression zones (40), arranged for providing a controlled compressionof said delivery container, and wherein the one or more compressionzones (40) are one or more areas of the delivery container having adifferent configuration than the remainder of said delivery container(2,2′,2″), and wherein the enema device (1,1′) comprises a non-returnvalve (39) arranged for preventing air from being drawn into thedelivery container (2,2′,2″), and wherein the delivery container fluidlycommunicates with the applicator nozzle only through the non-returnvalve.
 2. The enema device (1,1′) according to claim 1, wherein thedelivery container (2,2′,2″) comprises a bottom section (7) with a firstcross-section (8) in the shape of an oval (9), and a top section (10)with a second cross-section (11) in the shape of an oval (12), andwherein a major axis (Xa) of the first cross section (8) is larger thana major axis (Xb) of the second cross section (11), and a minor axis(Ya) of the first cross section (8) is larger than a minor axis (Yb) ofthe second cross section (11).
 3. The enema device (1,1′) according toclaim 2, wherein the ratio of the minor axis (Ya,Yb) to the major axis(Xa,Xb) of said oval is ⅔ or lower, respectively.
 4. The enema device(1,1′) according to claim 1, wherein the non-return valve (39) isarranged for preventing from being drawn into the delivery container(2,2′,2″) during operation.
 5. The enema device (1,1′) according toclaim 1, wherein the delivery container (2,2′,2″) is made of a resilientdeformable material with a memory.
 6. The enema device (1,1′) accordingto claim 1, wherein the one or more compression zones (40) constituteless than 50% of a surface area of the delivery container (2,2′,2″). 7.The enema device (1; 1′) according to claim 1, wherein the one or morecompression zones (40) are provided by adjusting a wall thickness of thedelivery container (2′) in the one or more compression zones.
 8. Theenema device (1,1′) according to claim 1, wherein the one or morecompression zones (40) are provided by reducing a wall thickness of thedelivery container (2″) in one or more bending lines (44).
 9. The enemadevice (1,1′) according to claim 1, wherein the one or more compressionzones are provided by providing reinforcement ribs at an inside and/oran outside of the delivery container.
 10. The enema device (1,1′)according to claim 1, wherein the delivery container (2,2′,2″) is madeof different materials, and wherein the respective materials have adifferent hardness in order to define the one or more compression zones(40).
 11. The enema device (1,1′) according to claim 1, wherein thedelivery container (2,2′,2″) is arranged for being fully compressed by aforce of less than about 150 N.
 12. The enema device (1,1′) according toclaim 1, wherein the delivery container (2,2′,2″) is arranged such thatsaid delivery container (2,2′,2″) will not be compressed before a forceof between about 30 N and about 50 N is applied to the sides (16 a,16b,17 a,17 b) of said delivery container (2,2′,2″).
 13. The enema device(1,1′) according to claim 1, wherein the delivery container (2,2′,2″) isarranged for accommodating at least about 90 ml of enema.
 14. The enemadevice (1,1′) according to claim 1, wherein the enema device (1,1′)comprises a closure member (4) e.g. a hinged closable lid, comprising afirst closure part (18) arranged for being attached to the deliverycontainer (2,2′,2″), and a second closure part (21) arranged for beingseparated from or connected to the first closure part.
 15. The enemadevice (1,1′) according to claim 1, wherein a first opening (24) isprovided into the delivery container (2,2′,2″) when a second closurepart (21) is separated from the first closure part (18), and whereinsaid first opening (24) constitutes at least 50% of a cross-section (11)taken at a top section (10) of the delivery container (2,2′,2″).
 16. Theenema device (1,1′) according to claim 1, wherein a second closure part(21) comprises a female coupling part (27) arranged for releasablyconnecting a male coupling part (28) of the applicator nozzle (3) to theenema device (1,1′) and for providing a fluid communication between theapplicator nozzle (3) and the delivery container (2,2′,2″).
 17. Adelivery container (2,2′,2″) arranged for accommodating an enema and anapplicator nozzle (3) for dispersing the enema, and wherein the deliverycontainer 2,2′,2″) is arranged as a hand held pump and wherein across-section of said delivery container (2,2′,2″) has the shape of anoval, and wherein the delivery container (2,2′,2″) comprises one or morecompression zones (40), arranged for providing a controlled compressionof said delivery container, and wherein the one or more compressionzones (40) are one or more areas of the delivery container having adifferent configuration than the remainder of said delivery container(2,2′,2″), and wherein a non-return valve (39) is arranged forpreventing air from being drawn into the delivery container (2,2′,2″),and wherein the delivery container fluidly communicates with theapplicator nozzle only through the non-return valve.